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Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.

The Gastro Concepts Air Assist Device is a single-use device that is used to aid in maintaining air/CO2 and insufflation during a colonoscopy. The Air Assist, a single-use device, comprises a cylindrical body with a conical-shaped tip and an open channel for endoscope insertion. Positioned against the anus (not inserted into the rectum), it forms a temporary seal, maintaining air/CO2 insufflation leading to adequate colonic distension for enhanced visualization.

The provided text describes a 510(k) premarket notification for the "Gastro Concepts Air Assist" device. However, it does not contain the detailed acceptance criteria and study results typically found in a comprehensive study report for a device relying on artificial intelligence or complex statistical analysis.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than detailed performance metrics against specific acceptance criteria for AI-driven insights. It explicitly states, "No Clinical Testing was required for this product."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not present in the provided text.

The available information about "performance testing" is limited to bench tests.

Here's what I can extract regarding the performance testing:

Performance Testing (Bench)

The following bench tests were performed:

• Dimensional Testing
• Simulated Use
• Mechanical Properties: Structural integrity, compression and tension strength
• Leak Rate and Sealing Capability

Summary of Study Results:

• The bench testing demonstrated that the Air Assist device was able to withstand forces greater than expected during clinical use.
• The device was successful in reducing the leak rate during simulated colonic insufflation.
• The device meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process."

Key Missing Information (Based on your request categories):

1. Table of acceptance criteria and reported device performance: Not provided. The text only states that the device "meets the requirements" and "was successful" without quantifiable acceptance criteria or specific performance values.
2. Sample size used for the test set and data provenance: Not applicable/Not provided, as no clinical or specific dataset testing is detailed beyond general bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not provided. This is not an AI-driven device described in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is not an AI-driven device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as the performance evaluation relies on physical properties and simulated use, not diagnostic "ground truth."
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

In essence, the provided document describes a medical device where substantial equivalence is demonstrated through engineering bench tests and compliance with recognized standards, not through studies involving AI, human readers, or clinical data with expert-established ground truth.

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WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

WellCare Anoscope is composed of Anoscope, Introducer and Sleeve.The anoscopes are divided into the following models according to the way the components are configured and the differences in size : WellCare-ANO-Light Sterile . WellCare-ANO-Truncated Sterile.This is a single use, disposable device(s), provided sterile.

The provided text describes the regulatory clearance of the WellCare Anoscope by the FDA, primarily relying on non-clinical (bench) testing. There is no information about any study that proves the device meets specific performance criteria related to AI or human-in-the-loop performance. The device described is a physical medical instrument, an anoscope, not a software or AI-driven diagnostic tool. Therefore, many of the requested details, such as those pertaining to AI assistance, ground truth establishment, expert qualifications, adjudication methods, and training/test set sizes for AI, are not applicable to this submission.

Here's the relevant information based on the provided text, focusing on the acceptance criteria and the non-clinical study conducted for the WellCare Anoscope:

1. A table of acceptance criteria and the reported device performance

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The Applied Medical Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

The Applied Medical Anoscope consists of a one-piece polycarbonate half round channel with a tapered closed tip. The device retracts the anal sphincter and provides access to the anorectal anatomy during transanal procedures.

The provided document is an FDA 510(k) clearance letter for the Applied Medical Anoscope. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond general biocompatibility and functional performance tests.

The 510(k) summary (page 4) states: "The anoscope is a simple one-piece device that provides a passage into the anal canal. There are no recognized performance standards for access devices of this kind. Therefore, Applied Medical devised criteria by which to assess safety and efficacy, including a computer-aided simulation and a compression test."

This indicates that while some criteria and tests were performed, their details (specific quantitative acceptance criteria, the results of these tests, sample sizes, ground truth establishment, expert involvement, etc.) are not included in this publicly available 510(k) clearance document.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: Not detailed in the document.
2. Sample sizes used for the test set and the data provenance: Not detailed for the described "computer-aided simulation and a compression test."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing described is physical, not interpretive, and not detailed in the document.
4. Adjudication method for the test set: Not applicable based on the described tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical anoscope, not an AI or imaging device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical anoscope.
7. The type of ground truth used: Not applicable for the described physical tests.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of technological characteristics (page 4), noting minor differences like the pre-existence of a dedicated light source channel in the predicate vs. the subject's larger lumen and use of external light sources.
• Biocompatibility testing (page 4) against ISO 10993-1 endpoints (cytotoxicity, intracutaneous irritation, sensitization), which the device passed.
• Functional performance testing (page 4), which involved a "computer-aided simulation and a compression test." The details of these tests and their results are not provided.

In summary, this document is a regulatory clearance letter, not a detailed scientific study report. It states that the manufacturer "devised criteria" and conducted "computer-aided simulation and a compression test" to assess safety and efficacy, but it does not provide the specific quantitative acceptance criteria or the results of those tests.

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The GelPOINT® Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

GelPOINT Path is inserted into the anal canal to establish access to the rectum and lower sigmoid colon in preparation for transanal endoscopic surgery. The access channel lumen may be closed off with an airtight cap. The cap allows for insufflation of the surgical site. The cap is constructed of a gel material through which multiple sleeves may be placed. These sleeves establish ports that allow passage of a laparoscope and laparoscopic instruments without loss of insufflation. GelPOINT Path was previously cleared in access channel lengths ranging from 4.5cm to 15cm. The proposed clearance for the access channel length is 3.5cm to 15cm.

This document is a 510(k) summary for the GelPOINT® Path Transanal Access Platform, a medical device. It's a regulatory submission to the FDA, not a study report that details acceptance criteria and performance data in the typical sense of a clinical trial.

Therefore, many of the requested categories simply do not apply to this type of document because it describes a line extension of an already cleared device, not a new device requiring extensive de novo performance testing. The main argument for substantial equivalence is based on the lack of impact of the new feature (shorter access channel length) on already established safety and effectiveness.

Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This is because the submission is for a line extension of an already cleared device (K110792 and K133393). The argument is that the proposed change (shorter access channel length) does not impact the performance specifications already established for the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission is for a line extension of a device. It refers to performance testing done for the predicate devices (K110792 and K133393) but does not provide details on their sample sizes or data provenance. No new testing of this nature was conducted or reported for this specific submission (K171701).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is not relevant to a 510(k) submission for a line extension of an existing mechanical device. There is no "ground truth" to establish through expert review in the context of diagnostic accuracy for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring adjudication in the context of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a transanal access platform, not an AI-powered diagnostic tool. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a transanal access platform, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. There is no concept of "ground truth" in the context of diagnostic accuracy for this mechanical device's 510(k) submission. Safety and effectiveness would be established through performance testing related to its mechanical function, biocompatibility, sterility, etc. (as mentioned for the predicate devices), not through comparison to a diagnostic ground truth.

8. The sample size for the training set

Not applicable. This device is a transanal access platform; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for this mechanical device, there is no ground truth to establish for it.

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The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and therapeutic procedures by using additional accessories.

The subject device is inserted into the rectum to establish an access port into the lower sigmoid colon in preparation for transanal endoscopic microsurgery. The port lumen measures 40mm in diameter and may be capped off with an airtight lid. The lid allows the colon to be insufflated, thus enlarging the operative space. The airtight lid is constructed of a gel material through which multiple trocars may be placed. These trocars establish multiple ports that allow passage of laparoscopes and laparoscopic instruments without loss of insufflation. The design has all the functionality of a simple, two-piece proctoscope but with significant additional versatility, capability and effectiveness.

The provided text is a 510(k) summary for the GelPOINT Path Transanal Access Platform, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data to prove novel performance criteria. Therefore, many of the requested details about acceptance criteria and study design are not explicitly available in this document as would be for a de novo device or a more complex medical AI/ML product.

However, I can extract information related to the demonstration of "substantial equivalence," which is the core of this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document describes the device's technological characteristics and its comparison to a predicate device for the purpose of demonstrating "substantial equivalence." It does not define specific quantifiable acceptance criteria in the way one might for a diagnostic test (e.g., sensitivity, specificity thresholds) or for a new therapeutic intervention. Instead, the "acceptance criteria" are implied by the regulatory standard of substantial equivalence, meaning the device performs similarly to or better than a legally marketed predicate device without raising new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "There are no recognized standard tests that can challenge and compare these technological differences. Therefore, substantial equivalence was established based on a dimensional analysis of each device."

This indicates that a "test set" in the traditional sense of patient data or clinical samples was not used for this submission. The evaluation was based on a dimensional analysis and comparison of technological characteristics between the new device and the predicate device.

• Sample Size: Not applicable as no clinical test set was used for this specific comparison to demonstrate substantial equivalence.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As no clinical test set was used, there were no experts used to establish ground truth for a test set. The comparison was based on engineering and design specifications.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence based on design and function, not on comparative clinical effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is a physical surgical access platform, not an algorithm or AI/ML device. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (Sapimed S.P.A. Disposable Sigmoidoscope/proctoscope; K070915 and Applied Medical Resources GelPOINT Path Transanal Access Platform; K110792), combined with engineering and design specifications for both devices. The "dimensional analysis" served as the primary method to compare the new device to this established baseline.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI/ML system requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a physical medical device and not an AI/ML system requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" in this 510(k) submission is a non-clinical comparison based on technological characteristics and dimensional analysis between the new GelPOINT Path Transanal Access Platform and its predicates (especially the Sapimed proctoscope and the previously cleared GelPOINT Path K110792).

The key points of this "study" are:

• Objective: To demonstrate that the GelPOINT Path Transanal Access Platform is "substantially equivalent" to legally marketed predicate devices.
• Methodology:
  • Identification of Predicate Devices: K070915 (Sapimed S.P.A. Disposable Sigmoidoscope/proctoscope) and K110792 (Applied Medical Resources GelPOINT Path Transanal Access Platform). The submission states the current device's design is unchanged from K110792.
  • Comparison of Intended Use: The intended use of the current device is unchanged from K110792, and it is compared to the Sapimed proctoscope.
  • Comparison of Technological Characteristics: A detailed comparison was made on features like:
    • Dilation of the anus
    • Insertion method (dilator)
    • Ability to allow instrument insertion (including endoscopes)
    • Materials (polymers)
    • Disposability
    • Insufflation capability
  • Identification of Differences and Their Impact: The differences (e.g., larger cannula, CO2 pump insufflation, suturing capability, more access ports) were analyzed. The conclusion was that these differences provided "superior technological capabilities" and "increased effectiveness" (e.g., larger operative field via better insufflation) without raising new questions of safety or effectiveness, essentially making the device a more versatile and capable proctoscope.
  • Lack of Clinical Testing: The document explicitly states, "There are no recognized standard tests that can challenge and compare these technological differences. Therefore, substantial equivalence was established based on a dimensional analysis of each device." This means no new clinical trials or patient data studies were conducted as part of this specific submission to demonstrate performance against acceptance criteria.
• Conclusion: The subject device is substantially equivalent in performance to the Sapimed proctoscope but has numerous technological advantages that increase effectiveness. Therefore, the indications for use could be updated by incorporating the indications of the Sapimed device.

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The THD N-Ano Anoscopes, are intended for physician use to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.

The disposable, not sterile THD N-ano anoscope is a disposable, not sterile anoscope with an integrated LED light source. The device is designed for the examination o the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures. The light source is integrated on the handle. Differently than predicate devices (Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope - K103647) disposable, not sterile THD N-ano Anoscope does not have any accessory and is available only "not sterile"

The provided text describes a 510(k) summary for the THD N-ANO ANOSCOPE, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in a clinical or diagnostic setting. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in the provided text.

The document highlights modifications made to the THD N-ANO ANOSCOPE compared to its predicate device (THD S.p.A. Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope, K103647). The review process involves design control activities, risk analysis, and a declaration of conformity, aiming to ensure that the modifications do not adversely affect the safety and performance of the device.

Here's a breakdown of the information that can be extracted or deduced from your input:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. Instead, the "acceptance criteria" are implied to be substantial equivalence to the predicate device, meaning the modified device performs as safely and effectively as the original device.

The reported "performance" relates to the design and materials of the device, rather than diagnostic metrics.

• LED light source block eliminated (due to handle modification).
• Cover of LED light source circuit made of ABS Terluran (vs. ABS Lustran in predicate).
• Dimensions are "not more critical than dimensions of predicate devices" (Length: 105mm vs. 90mm/130mm, Diameter: 21.7mm vs. 22.1mm/26.1mm/15.1mm).
• White polypropylene tip on introducer eliminated. |
  | Intended Use Equivalence | The THD N-Ano Anoscope is indicated for the same intended use: "to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures." |
  | Materials Equivalence | Manufactured with the same materials and the same process as the predicate family of devices. |

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a test set or clinical study to evaluate diagnostic performance. The evaluation is focused on engineering and design changes and their impact on substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth for a test set is established in this document as it's not a clinical performance study.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication is described for clinical performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention any MRMC study or an assessment of human reader improvement with or without AI assistance. This device is a physical instrument, not an AI or diagnostic software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an algorithm or AI-driven device, so a standalone performance study in that context is not relevant.

7. Type of Ground Truth Used

Not applicable in the context of diagnostic performance. The "ground truth" here is the predicate device and its established safety and efficacy, to which the modified device is compared through design and material analysis.

8. Sample Size for the Training Set

Not applicable. No training set is mentioned as this is not an AI or machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Document's Focus:

This 510(k) summary is for a medical device (anoscope) where the manufacturer is seeking FDA clearance based on substantial equivalence to a previously cleared predicate device. The changes described are primarily related to mechanical design (handle, LED light source integration, dimensions) and material of a component. The "study" referenced implicitly is the design control process, risk analysis, and material compatibility assessment to demonstrate that these modifications do not alter the fundamental safety or effectiveness of the device compared to the predicate. It is not a clinical trial evaluating diagnostic accuracy or a performance study of AI.

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The AnoSPEC Disposable Anoscope with light is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

AnoSPEC Disposable Anoscope with light

The provided document is a 510(k) clearance letter from the FDA for the "AnoSPEC Disposable Anoscope with light." This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or details about the training set.

The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive performance studies with specific acceptance criteria that would typically be detailed in a separate clinical or non-clinical performance report.

In summary, none of the requested information can be extracted from the provided text. The document only provides the following:

• Device Name: AnoSPEC Disposable Anoscope with light
• Regulation Number: 21 CFR § 876.1500
• Regulatory Class: II
• Product Code: FER
• Indications for Use: The AnoSPEC Disposable Anoscope with light is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

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The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures by using additional accessories.

The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope are disposable, sterile rectoscopes, proctoscope and anoscopes with a light source which can be external or integrated on the handle. The devices are designed for the examination and treatment of anus (anoscopes) and the examination of rectum (proctoscopes and rectoscopes). The devices consist of plastic anoscopes, proctoscopes for diagnostic or therapeutic use. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctoscopes and Rectoscopes and Surgical Proctoscopes. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope includes both models which require the external light source and models which not require the external light source. In the latter case the light source is integrated on the handle. The external light source is provided as an accessory of the device family and it can be the THD Shining Light and the THD pen light.

The manufacturer, THD S.p.A., submitted a 510(k) premarket notification for a "Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope". This submission is for device modifications to an already approved product family (K103647). The modifications include the availability of THD Light-scope devices in sterile condition and changes to the handle materials (ABS Terluran and ABS Novodur replacing ABS Lustran).

The document does not describe a study involving AI, human readers, or a test set in the traditional sense of diagnostic or clinical performance studies. Instead, the provided text details design verification tests to ensure the updated device's safety and effectiveness due to manufacturing material and sterilization changes.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" (design verification tests) that proves the device meets them, as much as possible given the context of a medical device modification submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not detail specific sample sizes for these design verification tests. The tests are related to material changes and sterilization processes, so "test set" here refers to the samples of the modified devices subjected to validation. The data provenance is internal to THD S.p.A., an Italian company, performing design verification tests for a 510(k) submission to the FDA. These would be prospective tests performed on the modified devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For these types of engineering and sterilization validation tests, "experts" typically refers to qualified engineers, microbiologists, and materials scientists involved in the testing and evaluation process. The document does not specify the number or qualifications of these experts. The "ground truth" for these tests is established by industry standards, regulatory requirements, and validated test methodologies for sterilization efficacy and material biocompatibility/durability.

4. Adjudication Method for the Test Set

Not applicable in the context of these design verification tests. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or image interpretation by multiple readers. Here, the outcome of the tests (e.g., successful sterilization, material integrity) is determined by objective measurements against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for device modifications concerning materials and sterilization, not a diagnostic AI device requiring clinical performance or human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (anoscope, proctoscope, rectoscope, light-scope), not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these design verification tests is based on:

• Sterilization Validation Standards: Demonstrating that the sterilization process achieves a specified sterility assurance level (SAL), typically accepted industry standards (e.g., ANSI/AAMI/ISO 11135 for ethylene oxide, or similar for other methods).
• Material Safety Standards: Demonstrating the biocompatibility and physical properties of the new handle materials meet safety and performance requirements, often referencing ISO standards (e.g., ISO 10993 for biocompatibility) and relevant engineering specifications.
• Packaging Integrity Tests: Ensuring the packaging maintains sterility and product integrity over the claimed shelf life, according to ISO and ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set in that context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the device's technical validation (as described above in point 7) is established through adherence to recognized international and national standards for medical device manufacturing, sterilization, and materials.

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The GelPOINT Path is indicated for multiple instrument or camera access through the anus for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision, and fistula repair.

The GelPOINT Path is a sterile, single use, disposable surgical instrument designed to provide multiple instrument or camera access into the rectal cavity and lower sigmoid colon. The device is used in concert with standard laparoscopic instruments and is substantially equivalent to the predicate device in intended use, concept, function and performance.

The provided text describes a 510(k) submission for the GelPOINT Path Transanal Access Platform, a surgical device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance.

Therefore, many of the requested sections (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, specific ground truth methods) are not applicable as they relate to a different type of evaluation (e.g., AI/ML algorithm validation) than what is presented in this 510(k) summary for a surgical instrument.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the same way they would be for an AI/ML algorithm. Instead, the submission describes the overall goal of demonstrating "substantial equivalence" to the predicate device in specific performance aspects. The "acceptance criteria" are implied to be meeting or matching the performance of the predicate device (Covidien SILS Port) in these areas.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of data or images. This 510(k) is for a physical surgical device, and testing would involve physical methods rather than data sets. The document mentions "dedicated test method" but does not provide details on sample sizes of devices tested or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context would likely refer to objective measurements of the device's physical performance, not subjective expert assessment of data.

4. Adjudication method for the test set

Not applicable. This concept is not relevant to the evaluation of this physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical surgical access platform, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device would be established through objective engineering and performance testing. The "Conclusions Drawn From Testing" (rapid insufflation, maintaining insufflation pressures, retention) imply quantitative or qualitative measurements were taken to compare the GelPOINT Path against the Covidien SILS Port. The specific methodologies (e.g., pressure measurement, flow rate measurement, physical retention force testing) are not detailed but are standard for evaluating such devices.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. This device does not use a "training set."

Summary of Study:

The study conducted was a nonclinical performance comparison of the GelPOINT Path Transanal Access Platform against its predicate device, the Covidien SILS™ Port.

• Objective: To confirm substantial equivalence in performance characteristics related to insufflation and retention.
• Methodology: Applied Medical created a "dedicated test method" focusing on:
  • Maximum insufflation flow rate capability
  • Sealing capability to allow and maintain insufflation
  • Establishing retention in the rectum
  • While specific details of the test methods (e.g., number of devices tested, experimental setup, criteria for "rapid," "maintaining," and "retention") are not provided in this summary, the conclusion states that the GelPOINT Path was found to be "substantially equivalent" in these three areas.
• Conclusion: The tests supported the substantial equivalence argument for the GelPOINT Path by demonstrating comparable performance to the predicate device in the specified functional aspects.

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The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope are disposable not sterile rectoscopes, proctoscopes and anoscopes with a light source external or integrated on the handle. The devices are designed for the examination and treatment of the anal (anoscopes) and rectum (proctoscopes and rectoscopes) examination. The devices consist of transparent plastic anoscope, proctoscope or rectoscope for diagnostic or therapeutic use. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctocope and Rectoscope and Surgical Proctoscopes. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope include both models which require the external light source and models which not require the external light source, in this case the light source is integrated on the handle. The external light source is provided as accessory of the family and it can be the THD Shining Light and the THD pen light.

Here's an analysis of the provided text regarding the acceptance criteria and study for the THD disposable anoscopes, proctoscopes, rectoscopes, and light-scope:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests performed are described as "Design verification and effectiveness test," "Safety and electromagnetic tests," and "Design verification." These descriptions typically refer to internal engineering and functional testing rather than clinical studies with human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention using experts to establish ground truth for a test set. The tests appear to be related to the device's physical and functional properties, as opposed to diagnostic performance requiring expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of method is typically used in clinical trials where multiple readers interpret results to establish a consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned in the provided text. The submission is for device modifications to an already cleared predicate device, focusing on functional and safety aspects of the changes rather than clinical effectiveness comparisons.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a medical device (anescope, proctoscope, rectoscope) for direct observation and intervention, not an imaging or algorithmic diagnostic device. Therefore, a standalone (algorithm only) study is not applicable and was not performed.

7. Type of Ground Truth Used

The ground truth for the "tests performed" appears to be based on engineering specifications, safety standards, and functional requirements to ensure the device's "safety and effectiveness." It is not based on expert consensus, pathology, or outcomes data in the clinical sense for these verification tests.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device's verification and validation process described. Training sets are typically used for machine learning algorithms, which are not involved here.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set in the context of this device and its studies, the method for establishing its ground truth is not applicable.

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